CE Marking Readiness: Find Your Conformity Route and Close Technical File Gaps
CE marking readiness for manufacturers and importers selling into Europe. We identify the EU laws and harmonised standards that apply to your product and the conformity route each one requires. Then we review your technical file against them, before a notified body, distributor, or market surveillance authority does.
What Is CE Marking?
CE marking is the manufacturer's declaration that a product meets every EU law that applies to it. It is required for products covered by laws that call for it, such as machinery, electrical equipment, radio devices, toys, PPE, and medical devices. With it, a product can be sold across the European Economic Area. Without it, customs, distributors, and market surveillance authorities can stop it.
Most CE marking is self-declared. The manufacturer picks the right route, tests against harmonised standards, builds a technical file, and signs an EU Declaration of Conformity. Higher-risk products also need a notified body, an organization designated by an EU country to assess that product type.
Accredify Global is not a notified body and does not issue CE certificates. We give you an independent readiness assessment, so you know your route and your gaps before you spend money on testing or a notified body.
CE Marking in 2026: New Regulations Replace Old Directives
Cybersecurity is now part of the CE mark. Since 1 August 2025, internet-connected radio equipment must meet cybersecurity requirements under the Radio Equipment Directive. The Cyber Resilience Act goes further for products with digital elements. Its reporting duties start on 11 September 2026, and its main requirements apply from 11 December 2027.
Machinery and construction products have new rules. The Machinery Regulation (EU) 2023/1230 replaces the Machinery Directive from 20 January 2027. The new Construction Products Regulation (EU) 2024/3110 has applied since 8 January 2026, with a long transition alongside the old one.
Great Britain keeps accepting the CE mark. CE marking is recognized indefinitely in Great Britain for many product areas, including machinery, electrical and radio equipment, toys, and PPE. Medical devices and construction products follow separate rules.
Sources: Machinery Regulation 2023/1230 (EU-OSHA) · CPR 2024/3110 (OIB) · CE marking in Great Britain (GOV.UK)
CE Marking Routes: Self-Declaration or Notified Body?
The law, and the product's risk, decide whether you can declare conformity yourself.
| Product area | Main EU law | Usual route |
|---|---|---|
| Low-voltage electrical equipment | Low Voltage Directive, EMC Directive, RoHS | Self-declaration with internal production control |
| Radio and connected devices | Radio Equipment Directive | Self-declaration, or a notified body where standards are not fully applied |
| Machinery | Machinery Directive, then Regulation 2023/1230 | Self-declaration for most; notified body for listed high-risk machines |
| Personal protective equipment | PPE Regulation (EU) 2016/425 | Notified body for categories II and III |
| Pressure equipment | Pressure Equipment Directive | Depends on category; notified body above the lowest |
| Medical devices | MDR (EU) 2017/745, IVDR (EU) 2017/746 | Notified body for most classes above the lowest |
| Toys | Toy Safety rules | Self-declaration; EU-type examination where standards are not applied |
Many products fall under several laws at once, as automotive and aerospace suppliers know well. A smart appliance, for example, may need the radio, EMC, RoHS, and ecodesign rules, and soon the Cyber Resilience Act. The declaration must list every law that applies. Missing one is among the most common reasons a technical file fails review.
What a CE Marking Technical File Must Contain
Authorities can ask for it at any time. This is what our readiness review checks.
| Section | What it needs | Gaps we often find |
|---|---|---|
| Product description | Models, variants, and intended use | Variants sold but not covered |
| Applicable laws and standards | Every law, with dated standard references | Superseded standard versions |
| Risk assessment | Hazards, risks, and how each is controlled | Generic templates not tied to the design |
| Design and manufacturing data | Drawings, circuit diagrams, and bill of materials | Outdated after design changes |
| Test reports | Results against each standard | Reports for a different model or old firmware |
| Instructions and labels | Safety information in the right languages | Missing warnings or translations |
| EU Declaration of Conformity | Signed, listing laws and standards | Laws missing from the declaration |
Test reports carry the most weight. Laboratories accredited to ISO/IEC 17025 for the relevant tests give the most confidence. We check that each report covers the exact model, the right standard version, and any later design or firmware changes.
Who Needs a CE Marking Readiness Assessment?
Anyone placing regulated products on the EU market, wherever they are based.
Exporters entering the EU for the first time, who also need an EU-based responsible person for many products.
Connected products facing radio cybersecurity rules now and the Cyber Resilience Act next.
Companies preparing for the Machinery Regulation in January 2027.
Firms that must check the manufacturer's file before selling under their own name.
Marketplace sellers whose listings can be removed without valid conformity documents.
Teams mapping the MDR route before choosing a notified body.
How Our Product Readiness Assessment Works
Five steps, ending in a clear action list before you commit to testing or a notified body.
Launching in the EU on a fixed date? Share it in your scoping review so the assessment fits your plan. Our certification process guide explains how quality system audits run alongside.
Book a free scoping reviewCE Marking Readiness Cost and Timeline
There is no list price. The cost follows your products and paperwork, and a free scoping review gives you a tailored proposal.
What shapes the effort
- Products — how many models and variants
- Laws — how many directives and regulations apply
- Documentation — how complete your file is today
- Software — connected or software-driven functions
Typical timeline
| Readiness assessment | 2–6 weeks |
|---|---|
| Testing | Set by your laboratory |
| Notified body, if needed | Set by the body you choose |
A quality system shortens later stages. Several conformity routes rely on production quality assurance, and an accredited ISO 9001 or ISO 13485 certificate shows a notified body that manufacturing is controlled.
Questions to Ask Before You Hire Product Compliance Support
How Accredify Global answers the questions manufacturers ask most.
| Question | Accredify Global's answer |
|---|---|
| Can you issue our CE certificate? | No. We are not a notified body. |
| Can you tell us if we need a notified body? | Yes. Route mapping is the first step. |
| Do you write the technical file? | No. We review it and report the gaps. |
| Do you test products? | No. We check the lab reports you have. |
| Do you give legal advice? | No. Interpretation stays with your counsel. |
| How is it priced? | A tailored proposal after a free scoping review. |
Frequently Asked Questions About CE Marking
Answers on certificates, notified bodies, technical files, new rules, cost, and timeline.
What is CE marking?
CE marking is the manufacturer's declaration that a product meets all EU laws that apply to it. It lets the product move freely in the European Economic Area. It is required only for products covered by EU laws that call for it, such as machinery, electrical equipment, radio equipment, toys and medical devices.
Is there a CE marking certificate?
Not in the way most people expect. For most products, the manufacturer signs an EU Declaration of Conformity and affixes the mark. Only where the law requires a notified body does a third party issue a certificate, such as an EU-type examination certificate.
Does Accredify Global issue CE certificates?
No. Accredify Global is not a notified body. We provide an independent readiness assessment: we identify the route that applies to your product and review your technical file against it. Where a notified body is required, you apply to one listed in the EU's NANDO database.
When do I need a notified body?
It depends on the law and the product's risk. Many electrical and electronic products can be self-declared. Higher-risk products, such as certain machinery, personal protective equipment, pressure equipment and most medical devices, need a notified body.
What goes in a CE technical file?
A product description, the applicable laws and standards, a risk assessment, design and manufacturing information, test reports, user instructions, and the signed Declaration of Conformity. You must keep it for ten years after the last product is placed on the market under most laws.
What changes for machinery in 2027?
The Machinery Regulation (EU) 2023/1230 applies from 20 January 2027 and replaces the Machinery Directive. It adds requirements for software, cybersecurity and machines with self-evolving behavior, and allows digital instructions.
How does the Cyber Resilience Act affect the CE mark?
Products with digital elements will need to meet cybersecurity requirements to carry the CE mark. Reporting duties apply from 11 September 2026, and the main obligations apply from 11 December 2027.
Do radio products need cybersecurity for the CE mark now?
Yes. Since 1 August 2025, internet-connected radio equipment, wearables and toys must meet cybersecurity requirements under the Radio Equipment Directive's delegated regulation.
Is the CE mark accepted in the UK?
In Great Britain, the CE mark is accepted indefinitely for many product areas, including machinery, electrical and radio equipment, toys and PPE. Medical devices and construction products follow separate rules, so check your product.
What changed for construction products?
The new Construction Products Regulation (EU) 2024/3110 applies from 8 January 2026. It runs alongside the old regulation during a long transition, and it adds environmental sustainability information over time.
Does ISO 9001 help with conformity assessment?
Yes, for some routes. Several conformity routes rely on a quality system for production, and an accredited ISO 9001 or ISO 13485 certificate gives evidence of consistent manufacturing. It does not replace the CE process itself.
Do you write our technical file or Declaration of Conformity?
No. As an independent assessor we review your documentation and report the gaps. Your engineers, or a consultant you choose, prepare the documents, and the manufacturer signs the declaration.
Who does the product testing?
Testing is done by laboratories, ideally accredited to ISO/IEC 17025 for the tests you need, or by your own lab where the law allows. We check that the reports cover the right standards and versions.
How long does a readiness assessment take?
Most assessments take two to six weeks, depending on how many products, laws and standards apply. Notified body timelines are set separately by the body you choose.
What does a readiness assessment cost?
There is no list price. The cost follows the number of products, the laws that apply and the state of your documentation. A free scoping review gives you a tailored proposal.
Know Your Conformity Route Before You Pay for Testing
Tell us about your products and target markets. We'll map the EU laws and routes that apply and send a tailored proposal.
Book your free scoping review →Last reviewed by the Accredify Global compliance team.